ANADA Number: 200-375

Proprietary Name HeifermaX™ 500 / Rumensin® / Tylan®
Sponsor Ivy Laboratories, Division of Ivy Animal Health, Inc.
Sponsor Address 8857 Bond Street
Overland Park, KS    66214
USA
Ingredients Melengestrol Acetate
Monensin Sodium
Tylosin Phosphate
Species Cattle, beef, heifers fed in confinement for slaughter
Routes of Administration Per Os
Dose Form Medicated feed
Drug Form Type A Medicated Article
This Document (200-375) Was Pioneered By:     Pharmacia & Upjohn Co.
Dispensing Status OTC
Withdrawal Time Zero withdrawal
Dosage Amount,
Indications
& Limitations

558.342 Melengestrol acetate.

Specifications: Dry Type A medicated articles containing 100 or 200 milligrams per pound or liquid Type A article containing 500 milligrams per pound

Conditions of use:

Cattle (heifers fed in confinement for slaughter)

Amount: Melengestrol acetate, 0.25 to 0.50 milligram per head per day, plus monensin (as monensin sodium) at 50 to 360 milligrams per head per day, plus tylosin (as tylosin phosphate), 60 to 90 milligrams per head per day. To attain this amount: Add 0.5 to 2.0 pounds per head per day of a liquid or dry medicated feed containing 0.125 to 1.0 milligram of melengestrol acetate per pound to a medicated feed containing 5 to 30 grams of monensin and 8 to 10 grams of tylosin per ton; or Add 0.5 to 2.0 pounds per head per day of a liquid or dry medicated feed containing 0.125 to 1.0 milligram of melengestrol acetate plus 25 to 720 milligrams of monensin per pound to 4.5 to 18 pounds of a dry medicated feed containing 10 to 40 grams of tylosin per ton; or Add 0.5 to 2.0 pounds per head per day of a dry pelleted medicated feed containing 0.125 to 1.0 milligram of melengestrol acetate (from a dry Type A article), 25 to 600 milligrams of monensin, plus 45 to 180 milligrams of tylosin per pound to a ration of non-medicated feed.

Indications: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii; and for reduced incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes.

Limitations: For heifers fed in confinement for slaughter.

Tolerances

A tolerance of 0.10 part per million (ppm) in cattle liver, 0.05 ppm in muscle, kidney, and fate.

A tolerance of 0.05 ppm in goats edible tissue.

A tolerance for residue of monensin in chickens, turkeys and quail is not needed.

A tolerance for residues of monensin in milk is not needed.

Tolerances are established for residues of tylosin in edible products of animals as follows:

a. Chickens and turkeys: 0.2 part per million (negligible residue) in uncooked fat, muscle, liver, and kidney.

b. Cattle: 0.2 part per million (negligible residue) in uncooked fat, muscle, liver, and kidney.

c. Swine: 0.2 part per million (negligible residue) in uncooked fat, muscle, liver, and kidney.

d. Milk: 0.05 part per million (negligible residue).

e. Eggs: 0.2 part per million (negligible residue).

A tolerance of 25 parts per billion is established for residues of the parent compound, melengestrol acetate, in fat, of cattle.